本文件规定了氧气浓缩器及其附件（以下简称ME设备）的基本安全和基本性能要求，旨在提高输送给单个患者的气体的氧气浓度。此类氧气浓缩器通常用于家庭医疗环境，供单个患者在各种环境中使用，包括任何私人和公共交通以及商用飞机。 注1:此类氧气浓缩器也可用于专业医疗设施。 本文件适用于运输可操作和非运输可操作的氧气浓缩器。本文件适用于集成到其他医疗设备、医用电气设备或医用电气系统中或与之一起使用的氧气浓缩器。 示例1具有集成氧气保存设备功能或加湿器功能的氧气浓缩器。 示例2与流量计支架一起使用的氧气浓缩器。 示例3氧气浓缩器作为麻醉系统的一部分，用于电力和麻醉气体物流供应有限的区域[2]。 示例4具有集成储液器功能或气瓶填充系统功能的氧气浓缩器。 本文件也适用于制造商拟连接到制氧机的附件，这些附件的特性可能影响制氧机的基本安全或基本性能。 注2此类附件可包括但不限于口罩、套管、延长管、加湿器、手推车、手提箱、外部电源和氧气保存设备。 本文件未规定与医用气体管道系统一起使用的氧气浓缩器的要求。 如果某一条款或子条款明确规定仅适用于医用电气设备，或仅适用于医用电气系统，则该条款或子条款的标题和内容应如此说明。如果不是这样，则本条款或子条款适用于医用电气设备和医用电气系统。 除通用标准7.2.13和8.4.1外，本文件的具体要求不包括本文件范围内医用电气设备或医用电气系统预期生理功能的固有危险。 注3:另见通用标准4.2。

This document specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment by a single patient in various environments including any private and public transportation as well as in commercial aircraft. NOTE 1 Such oxygen concentrators can also be used in professional healthcare facilities. This document is applicable to a transit-operable and non-transit-operable oxygen concentrator. This document is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems. EXAMPLE 1 An oxygen concentrator with integrated oxygen conserving equipment function or humidifier function. EXAMPLE 2 An oxygen concentrator used with a flowmeter stand. EXAMPLE 3 An oxygen concentrator as part of an anaesthetic system for use in areas with limited logistical supplies of electricity and anaesthetic gases[2]. EXAMPLE 4 An oxygen concentrator with an integrated liquid reservoir function or gas cylinder filling system function. This document is also applicable to those accessories intended by their manufacturer to be connected to an oxygen concentrator, where the characteristics of those accessories can affect the basic safety or essential performance of the oxygen concentrator. NOTE 2 Such accessories can include, but are not limited to, masks, cannulae, extension tubing, humidifiers, carts, carrying cases, external power sources and oxygen conserving equipment. This document does not specify requirements for oxygen concentrators for use with a medical gas pipeline system. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. NOTE 3 See also 4.2 of the general standard.